System and methods for assessing the neuromuscular pathway prior to nerve testing

ABSTRACT

The present invention involves a system and methods for assessing the state of the neuromuscular pathway to ensure further nerve tests aimed at detecting at least one of a breach in a pedicle wall, nerve proximity, nerve direction, and nerve pathology, are not conducted when neuromuscular blockade levels may decrease the reliability of the results.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.11/665,038 filed Apr. 9, 2007 (now issued as U.S. Pat. No. 8,538,539),which was the national state entry of PCT/US05/36089, filed on Oct. 7,2005, which claims priority to U.S. Provisional Patent Application Ser.No. 60/617,142 filed on Oct. 7, 2004, U.S. Provisional PatentApplication Ser. No. 60/622,494 filed on Oct. 26, 2004, and U.S.Provisional Patent Application Ser. No. 60/721,424 filed on Sep. 27,2005, the entire contents of which are hereby expressly incorporated byreference into this disclosure as if set forth in their entirety herein.

BACKGROUND OF THE INVENTION

I. Field of the Invention

The present invention relates generally to a system and methods aimed atsurgery, and more particularly to system and methods for testing theneuromuscular blockade level in a patient prior to conducting nervetests aimed at detecting pedicle breaches, nerve proximity, nervedirection, and nerve pathology.

II. Discussion of the Prior Art

Despite ongoing advances in surgical methods, neurological impairmentremains a serious concern during various surgical spine procedures. Themisplacement of a pedicle screw or inadvertent contact between asurgical instrument and nerve during surgery may result in undesirableconsequences, including pain, necessitation of revision surgeries, nervedamage, and a possible loss of muscle function. To avert suchconsequences, surgeons are increasingly relying on systems and methodsthat capitalize on the knowledge that electrically stimulating a nerveshould result in detectable muscle activity.

While these existing EMG systems are significant advancements within theart, proliferated use of neuromuscular blocking agents (musclerelaxants) during surgery present certain challenges with the use ofthese systems. More specifically, surgeons must wait for a period oftime to allow the neuromuscular blocking agents (NMBA) to wear offbefore initiating a nerve test, which increases surgery time and overallcost. NMBAs generally inhibit the neuromuscular pathway by binding toacetylcholine receptors on the postsynaptic membrane and hence, decreaseneuromuscular transmission (transfer of a motor nerve impulse into themuscle) relative to the number of receptors occupied at a given time.This inhibition of the neuromuscular pathway is commonly referred to asneuromuscular block or blockade (NMB). If the neuromuscular pathway issufficiently blocked, stimulation of a nerve will not result in theotherwise expected contraction of the corresponding muscle. NMB is anecessity during many surgical procedures in order to maintain a certainlevel of muscle relaxation, however, as mentioned it requires thesurgeon to wait for the NMB to wear off prior to initiating a nervetest. If the nerve test is conducted too soon the muscle may fail tocontract upon stimulation of the nerve and the stimulation current levelat which the nerve is stimulated will appear to be higher than it trulyis. This may create, in effect, a false positive wherein the surgeon maybelieve, for example, a pedicle wall has not been breached or a nervefarther from an instrument than it really is because of the erroneouslyhigh stimulation level detected.

The amount and metabolic rate of NMBA may vary from procedure toprocedure and person to person. In addition, the present systems retaintheir effectiveness up to a certain level of NMB. Together this makes itdifficult to determine when precisely nerve testing functions regaintheir effectiveness and surgeons must wait longer than necessary toensure accurate results, which results in additional surgical time andincreased costs. Being able to assess the neuromuscular pathway prior toinitiating nerve testing would reduce the amount of waiting time neededand would thus represent a savings in time and costs to both the surgeonand patient.

Neuromuscular pathway testing is currently performed by specialists(neurophysiologists) trained in assessing the neurophysiologicinformation graphically represented on traditional EMG systems. Whilethese individuals are oftentimes exceptionally skilled and highlytrained, there exists the potential for human error on their part inreading and/or monitoring such traditional EMG systems. Moreover, theneed for the neurophysiologist to assist in a surgical case addscomplexity and challenges in scheduling surgical procedures, in that theschedules of both individuals need to coincide for them to worktogether. This may disadvantageously cause a patient to wait, whileexperiencing pain and/or other issues, for the scheduling conflicts ofthe surgeon and neurophysiologist to resolve. Because theneurophysiologist performs the actual neuromuscular pathway testing,there exists the potential for communication gaps to occur between thesurgeon and the neurophysiologist such that the neuromuscular testingmay not be conducted as desired by the surgeon. Also, with the attendantactivity in the operating room (as well as other operating rooms wherethe neurophysiologist may be working), the possibility exists that theneuromuscular pathway testing may not be conducted in the desired mannerbased on inattentiveness of the neurophysiologist.

Based on the foregoing, a need exists for improved systems and methodsfor surgeon-directed nerve testing during surgery, and in particular aneed exits for improved systems and methods for combining neuromuscularpathway assessment and nerve testing capabilities, all being performedby the surgeon. The present invention is directed towards fulfillingthese needs.

SUMMARY OF THE INVENTION

The present invention includes a system and related methods forassessing the state of the neuromuscular pathway prior to and incombination with performing nerve testing functions aimed at detectingpedicle breaches during screw implantation, nerve proximity to surgicalinstruments employed in accessing a surgical target site, and nervepathology monitoring. Advantageously, the system and methods of thepresent invention are surgeon-directed, meaning the surgeon is capableof directing all such functionality without the need for aneurophysiologist.

According to a broad aspect, the present invention involves asurgeon-directed surgical system, comprising a control unit, a surgicalinstrument, and peripheral nerve stimulation electrodes. The controlunit has at least one of computer programming software, firmware andhardware capable of delivering a stimulation signal, receiving andprocessing neuromuscular responses due to the stimulation signal, andidentifying a relationship between the neuromuscular response and thestimulation signal. The surgical instrument has at least one stimulationelectrode electrically coupled to the control unit for transmitting astimulation signal within a surgical corridor. Peripheral nervestimulation electrodes are also coupled to the control unit fortransmitting a stimulation signal to peripheral nerves outside asurgical corridor. The control unit is capable of determining theneuromuscular blockade level and at least one of pedicle integrity,nerve proximity, nerve direction, and nerve pathology based on theidentified relationship between a stimulation signal and a correspondingneuromuscular response.

In a further embodiment of the surgical system of the present invention,the control unit is further equipped to communicate at least one ofalpha-numeric and graphical information to a user regardingneuromuscular pathway status, and at least one of pedicle integrity,nerve proximity, nerve direction, and nerve pathology.

In a further embodiment of the surgical system of the present invention,the surgical instrument may comprise at least one of a device fortesting screw placement integrity, a device for accessing a surgicaltarget site, and a device for maintaining contact with a nerve duringsurgery.

In a further embodiment of the surgical system of the present invention,the surgical instrument comprises a screw test probe and wherein thecontrol unit determines the degree of electrical communication betweenthe screw test probe and an exiting spinal nerve root to assess whethera pedicle has been breached by at least one of hole formation and screwplacement

In a further embodiment of the surgical system of the present invention,the surgical instrument comprises a nerve root retractor and wherein thecontrol unit determines nerve pathology based on the identifiedrelationship between the neuromuscular response and the stimulationsignal.

In a further embodiment of the surgical system of the present invention,the surgical instrument comprises a dilating instrument and wherein thecontrol unit determines the proximity and direction between a nerve andthe instrument based on the identified relationship between theneuromuscular response and the stimulation signal.

In a further embodiment of the surgical system of the present invention,the dilating instrument comprises at least one of a K-wire, anobturator, a dilating cannula, and a working cannula.

In a further embodiment of the surgical system of the present invention,the surgical instrument comprises a tissue retractor assembly andwherein the control unit determines the proximity between a nerve andthe instrument based on the identified relationship between theneuromuscular response and the stimulation signal.

BRIEF DESCRIPTION OF THE DRAWINGS

Many advantages of the present invention will be apparent to thoseskilled in the art with a reading of this specification in conjunctionwith the attached drawings, wherein like reference numerals are appliedto like elements and wherein:

FIG. 1 is a perspective view of an exemplary surgeon-directed surgicalsystem 10 capable of assessing the state of the neuromuscular pathwayand nerve testing functions aimed at detecting pedicle breaches, nerveproximity (detection), and nerve pathology;

FIG. 2 is a block diagram of the surgical system 10 shown in FIG. 1;

FIG. 3 is an exemplary screen display illustrating one embodiment of theof a drop down menu for navigating between different functions of thesystem 10 according to the present invention;

FIG. 4 is an exemplary screen display illustrating one embodiment of ageneral system setup screen;

FIG. 5 is an exemplary screen display illustrating one embodiment of aneuromuscular pathway test (a.k.a. “Twitch Test”) setup screen providingfor selection between Peripheral and Direct Stimulation modes accordingto the present invention;

FIG. 6 is a is a graph illustrating a plot of four electricalstimulation pulses employed during the neuromuscular pathway assessmentof the present invention;

FIG. 7 is a graph illustrating a method of increasing stimulationcurrent amplitude to determine a supramaximal current for use in theneuromuscular pathway (NMP) assessment of the present invention;

FIG. 8 is a graph illustrating an exemplary EMG response to the stimulusof FIG. 6 in the presence of little or no neuromuscular blockade (NMB).

FIG. 9 is a graph illustrating an exemplary EMG response to the stimulusof FIG. 6 wherein the fourth response is present but diminished;

FIG. 10 is a graph illustrating an exemplary EMG response to thestimulus of FIG. 6 wherein the fourth response has disappearedcompletely;

FIGS. 11-12 are exemplary screen displays illustrating variousembodiments of the NMP test function according to the present invention;

FIG. 13 is an exemplary screen display illustrating one embodiment of ascrew test setup screen according to the present invention;

FIG. 14-15 are exemplary screen displays illustrating variousembodiments of the Basic Screw Test function according to the presentinvention;

FIG. 16-17 are exemplary screen displays illustrating variousembodiments of the Basic Screw Test function according to the presentinvention;

FIG. 18-19 are exemplary screen displays illustrating variousembodiments of the Difference Screw Test function according to thepresent invention;

FIG. 20 is an exemplary screen display illustrating one embodiment of aDetection setup screen according to the present invention;

FIG. 21-22 are exemplary screen displays illustrating variousembodiments of the Nerve Detection function according to the presentinvention;

FIG. 23 is an exemplary screen display illustrating one embodiment of aNerve Retractor (pathology) setup screen according to the presentinvention;

FIG. 24 is an exemplary screen displays illustrating one embodiment ofthe Nerve Retractor function according to the present invention;

FIG. 25 is a graph illustrating a plot of the neuromuscular response(EMG) of a given myotome over time based on a current stimulation pulse(similar to that shown in FIG. 26) applied to a nerve bundle coupled tothe given myotome;

FIG. 26 is a graph illustrating a plot of a stimulation current pulsecapable of producing a neuromuscular response (EMG) of the type shown inFIG. 25;

FIG. 27 is an illustration (graphical and schematic) of a method ofautomatically determining the maximum frequency (F_(Max)) of thestimulation current pulses according to one embodiment of the presentinvention;

FIG. 28 is a graph illustrating a plot of peak-to-peak voltage (Vpp) foreach given stimulation current level (I_(Stim)) forming a stimulationcurrent pulse train according to the present invention (otherwise knownas a “recruitment curve”);

FIGS. 29A-29D are graphs illustrating a rapid current threshold-huntingalgorithm according to one embodiment of the present invention;

FIG. 30 is a series of graphs illustrating a multi-channel rapid currentthreshold-hunting algorithm according to one embodiment of the presentinvention;

FIG. 31 is a graph illustrating recruitment curves for a generallyhealthy nerve (denoted “A”) and a generally unhealthy nerve (denoted“B”) according to the nerve pathology determination method of thepresent invention;

FIGS. 32A-32E are exemplary screen displays illustrating one method ofannotating selected stimulation results according to one embodiment ofthe present invention;

FIG. 33 is an exemplary screen display illustrating a method ofgenerating a surgical report according to one embodiment of the presentinvention;

FIG. 34 is an exemplary screen display illustrating a method ofselecting between a full surgical report and/or a summary surgicalreport according to one embodiment of the present invention;

FIGS. 35A-35C is an exemplary representation of a summary reportaccording to one embodiment of the present invention; and

FIGS. 36A-36E is an exemplary representation of a full report accordingto one embodiment of the present invention.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Illustrative embodiments of the invention are described below. In theinterest of clarity, not all features of an actual implementation aredescribed in this specification. It will of course be appreciated thatin the development of any such actual embodiment, numerousimplementation-specific decisions must be made to achieve thedevelopers' specific goals, such as compliance with system-related andbusiness-related constraints, which will vary from one implementation toanother. Moreover, it will be appreciated that such a development effortmight be complex and time-consuming, but would nevertheless be a routineundertaking for those of ordinary skill in the art having the benefit ofthis disclosure. The systems disclosed herein boast a variety ofinventive features and components that warrant patent protection, bothindividually and in combination.

The present invention involves a surgeon-directed system and methods forassessing the neuromuscular pathway prior to and in combination withnerve testing procedures during surgery, including but not limited topedicle integrity assessments (screw test), nerve proximity assessments(direction), and nerve pathology assessments (nerve root retraction).FIG. 1 illustrates, by way of example only, a surgeon-directed surgicalsystem 10 capable of assessing the status of the neuromuscular pathwayduring a surgical procedure targeted to one of the lumbar, thoracic, orcervical regions of the spine, where nerve monitoring may beadvantageous. The surgical system 10 is further capable of carrying outnerve testing functions including, but not necessarily limited to,pedicle screw testing, nerve proximity testing and nerve pathologymonitoring. It is expressly noted that, although described hereinlargely in terms of use in spinal surgery, the surgeon-directed surgicalsystem 10 and related methods of the present invention are suitable foruse in any number of additional surgical procedures where neurologicalimpairment is a concern.

The surgeon-directed surgical system 10 includes a control unit 12, apatient module 14, an EMG harness 16 (including eight pairs of EMGelectrodes 18 and a return electrode 22 coupled to the patient module14), and a host of various surgical accessories 32 capable of beingcoupled to the patient module 14 via one or more accessory cables 30and/or coupling devices 42. The surgical accessories 32 may include, butare not necessarily limited to, devices for performing pedicle screwtests (such as a screw test probe 36), neural pathology monitoringdevices (such as a nerve root retractor 76), coupling devices forelectronically coupling surgical instruments to the system 10 (such aselectric coupling devices 42,52 and stimulator driver 68), accesscomponents (such as a K-wire 62, one or more dilating cannula 64, aworking cannula 66, and a tissue retraction assembly 70), and pilot holeforming components (such as a tap member 72, pedicle access probe 74, orother similar device), and devices for delivering peripheral stimulationsignals (such as a pair—one positive and one negative—of peripheralnerve stimulation (PNS) electrodes 25).

A block diagram of the surgical system 10 is shown in FIG. 2, theoperation of which is readily apparent in view of the followingdescription. The control unit 12 includes a touch screen display 26 anda base 28, which collectively contain the essential processingcapabilities for controlling the surgical system 10, preferably underthe direction of a surgeon. The touch screen display 26 is preferablyequipped with a graphical user interface (GUI) capable of communicatinginformation to the surgeon and receiving instructions from the surgeon.The base 28 contains computer hardware and software that commands thestimulation sources, receives digitized signals and other informationfrom the patient module 14, processes the EMG responses, and displaysthe processed data to the surgeon via the display 26. The primaryfunctions of the software within the control unit 12 include receivingcommands from the surgeon via the touch screen display 26, activatingstimulation in the requested mode (including “Twitch Test”(neuromuscular pathway assessment), “Basic Screw Test” and/or “DynamicScrew Test” (pedicle integrity assessment), “Detection” (nerveproximity), and “Nerve Retractor” (nerve pathology)), processing signaldata according to defined algorithms (described below), displayingreceived parameters and processed data, and monitoring system status.

The patient module 14 is connected via a data cable 28 to the controlunit 12, and contains the electrical connections to all electrodes,signal conditioning circuitry, stimulator drive and steering circuitry,and a digital communications interface to the control unit 12. In use,the control unit 12 is situated outside but close to the surgical field(such as on a cart adjacent the operating table) such that the display26 is directed towards the surgeon for easy visualization. The patientmodule 14 should be located between the patient's legs or affixed to theend of the operating table at mid-leg level using a bedrail clamp. Theposition selected should be such that the EMG electrodes 18 can reachtheir farthest desired location without tension during the surgicalprocedure.

In a significant aspect of the present invention, the informationdisplayed to the surgeon on the display 26 may include, but is notnecessarily limited to, alpha-numeric and/or graphical informationregarding NMP status, screw testing, nerve proximity, nerve pathology,myotome/EMG levels, stimulation levels, advance or hold instructions,and the instrument in use. In one embodiment (set forth by way ofexample only) the display includes the following components as set forthin Table 1:

TABLE 1 Screen Component Description Spine Image 100 An image of thehuman body/skeleton showing the electrode placement on the body, withlabeled channel number tabs on each side (1-4 on the left and right).Left and right labels will show the patient orientation. The channelnumber tabs may be highlighted or colored depending on the specificfunction being performed. Myotome & Level A label to indicate theMyotome name and corresponding Spinal Names 102 Level(s) associated withthe channel of interest. Menu 104 A drop down navigation component fortoggling between functions. Display Area 106 Shows procedure-specificinformation including stimulation results 120. Color Indication 108Enhances stimulation results with a color display of green, yellow, orred corresponding to the relative safety level determined by the system.In one embodiment, “Advance” or “Hold” instructions may be optionallydisplayed also corresponding to the relative safety level determined bythe system in the Detection mode. Function Graphics and/or name toindicate the currently active function Indicator 110 (Twitch Test, BasicScrew Test, Dynamic Screw Test, Difference Screw Test, Detection, NerveRetractor). In an alternate embodiment, Graphics and/or name may also bedisplayed to indicate the instrument in use, such as the dialator,K-wire, retractor blades, screw test instruments, and associated sizeinformation (if applicable) of the dilator, with the numeric size. If noinstrument is in use, then no indicator is displayed. Stimulation Bar112 A graphical stimulation indicator depicting the present stimulationstatus (e.g. on/off and stimulation current level) Sequence Bar 114Shows the last seven stimulation results and provides for annotation ofresults. EMG waveforms EMG waveforms may be optionally displayed onscreen along with 116 the stimulation results.

Switching between the various functions of the surgical system 10 may beaccomplished from a drop down menu 104, which is preferably accessiblefrom all screens on the GUI display 26. Selecting the menu button 118labeled, by way of example only, “Select Mode” expands the drop downmenu 104 as seen in FIG. 3. Using the menu 104 the surgeon or otherqualified user may open any of the functions by selecting the functiontab 110 corresponding to the desired function. Also from the menu 104,the user may optionally select to view the actual EMG waveforms 116alongside the numerical result coinciding with a particular stimulation.This is accomplished by selecting an EMG tab 122 associatedcorresponding to the desired function. It should be understood that thedrop down menu described above is only a preferred method of navigatingbetween functions and any of a number of different methods may be used.By way of example only, a menu bar containing the different functionbuttons may be constantly displayed across the top or bottom of thescreen.

A setup mode provides a simple means for selecting and/or changingvarious options and parameters associated with the functions of thesurgical system 10. A setup tab 124 is provided on the GUI display 26for accessing the setup mode, which preferably includes a separate setupscreen for each function. FIG. 4 is an exemplary illustration, set forthby way of example only, of a general system setup screen. From thesystem set up screen the user may adjust the system volume, adjust thefree run EMG volumes, change the EMG scale, turn different EMG channelson or off, set the date and time, conduct an impedance test to check theelectrical connection between the EMG electrodes and the patients skin,and shutdown the system 10. The remaining setup screens will be shownand discussed below in conjunction with their associated functions.

In a preferred embodiment, the surgeon-directed surgical system 10detects and monitors muscle activity using EMG (electromyogram). EMGmonitoring is preferably carried out utilizing the same equipment andconfiguration for all the functions of the surgical system 10 and willnow be described. EMG response monitoring is accomplished via 8 pairs ofEMG electrodes 18 placed on the skin over the major muscle groups of thelegs (four per side), a common electrode 20 providing a ground referenceto pre-amplifiers in the patient module 14, and an anode electrode 20providing a return path for the stimulation current. The EMG responsesprovide a quantitative measure of the nerve depolarization caused by theelectrical stimulus. Depending on the particular function, analysis ofthe EMG responses is used to determine the status of the neuromuscularpathway (NMP), pedicle integrity, nerve proximity or nerve pathology. Ifperipheral nerve stimulation is chosen for the NMP test according to thepresent invention, it is preferably targeted to a nerve innervating oneof the muscle groups to be monitored during the ensuing nerve tests. Indoing so, one pair of EMG electrodes 18 is utilized during both NMPtesting and the desired nerve testing, thereby eliminating the need foradditional electrodes and recording channels. By way of example only,the placement of EMG electrodes 18 for spinal surgery may be undertakenaccording to the manner described in Table 2 below:

TABLE 2 Channel Color ID Myotome Nerve Spinal Level Red Right 1 RightVastus Medialis Femoral L2, L3, L4 Orange Right 2 Right TibialisAnteriorPeroneal L4, L5 Yellow Right 3 Right Biceps Femoris Sciatic L5, S1, S2Green Right 4 Right Gastroc. Medial Post Tibialis S1, S2 Blue Left 1Left Vastus Medialis Femoral L2, L3, L4 Violet Left 2 Left TibialisAnterior Peroneal L4, L5 Gray Left 3 Left Biceps Femoris Sciatic L5, S1,S2 White Left 4 Left Gastroc. Medial Post Tibialis S1, S2

Although not shown, it will be appreciated that any of a variety ofelectrodes can be employed, including but not limited to surface padelectrodes and needle electrodes. It should also be appreciated that EMGelectrode placement has been shown and described, by way of exampleonly, as it relates to use of the surgical system 10 during proceduresin the lumbar spine. However, electrode placement depends on thesurgical area and particular nerves at risk, and as such is not limitedto the legs. By way of example, the surgical system 10 and its variousfunctions may be utilized in the cervical and thoracic regions as well,wherein, it may be necessary to deploy the EMG electrodes 18 on theupper or mid regions of the body, respectively.

The surgical system 10 may perform NMP assessments by electricallystimulating a peripheral nerve via PNS electrodes 25 placed on the skinover the nerve and/or by direct stimulation of a spinal nerve using asurgical accessory such as screw test probe 36. Evoked responses fromthe muscles innervated by the stimulated nerve are detected andrecorded, the results of which are analyzed and a relationship betweenat least two responses or a stimulation signal and a response isidentified. The identified relationship provides an indication of thestatus of the NMP (e.g. blocked, unblocked, questionable). As discussedin greater detail below, the identified relationship may include, but isnot necessarily limited to, one or more of magnitude ratios betweenmultiple evoked responses and/or the presence or absence of an evokedresponse relative to a given stimulation signal or signals. Details ofthe test indicating NMP status and the relative safety of continuing onwith nerve testing are conveyed to the surgeon via the screen display26.

According to one embodiment of the present invention, NMP testing may becarried out utilizing direct stimulation and/or peripheral stimulation.The decision to use the Direct or Peripheral Stimulation modes should bebased on the particular needs, experience, and preferences of theoperating surgeon. Choosing between the modes is preferably accomplishedon the GUI display 26 from the Twitch Test setup screen, illustrated inFIG. 5. In direct stimulation mode a surgical accessory 32, such asscrew test probe 36, is used to stimulate in the direct vicinity of anerve in the surgical area of interest while evoked responses aremonitored, preferably, via EMG electrodes 18. In peripheral stimulationmode, NMP testing may (by way of example only) be conducted on thePeroneal Nerve with evoked responses monitored from the TibialisAnterior muscle. Accordingly, the PNS electrodes 25 are positioned onthe skin above the Peroneal Nerve (preferably at the fibular head) and acorresponding pair of muscle activity sensors, such as EMG electrodes18, are situated on the Tibialis Anterior. The NMP test is administeredby delivering a stimulation signal (by having the surgeon activate astimulation button on the hand piece 34), preferably consisting of fourelectrical pulses of equal current, through a surgical accessory 32(direct stimulation mode) or PNS electrodes 25 (peripheral stimulationmode). Under normal body conditions (i.e., no NMB) the four electricalpulses each produce one muscle contraction or evoked response. As theneuromuscular pathway becomes inhibited by the neuromuscular blockingagents, the evoked responses diminish, beginning with the loss of thefourth response and continuing until no evoked responses occur,indicating a complete NMB.

FIG. 6 is a graphical illustration of an exemplary stimulation signaldelivered by the surgeon-directed surgical system 10 during the NMPtest. The electrical pulses may be delivered at a single frequencyselected from a range of, by way of example only, 0.5 Hz to 5 Hz, andpreferably a frequency of 2 Hz (0.5 s intervals) may be employed. Eachpulse should last for an identical period of time (i.e. have the samepulse width) selected from a range of, by way of example only, 100 μs to500 μs, with a preferred pulse width of 200 μs. The short pulse width ispreferable because the Peroneal Nerve is stimulated in close proximityto the muscle it innervates, making direct stimulation of the muscle aconcern in Peripheral Stimulation mode. However, nerve fibers areapproximately four times more sensitive than muscle fibers and the short200 μs pulses will diminish the possibility of bypassing the nerve anddirectly stimulating the muscle. This ensures that any musclecontraction recorded during the peripheral nerve stimulation is causedby transmission of a motor nerve impulse across the neuromuscularjunction.

In one embodiment of the present invention, the stimulation pulses ofthe NMP test may be delivered at a supramaximal current, such that allthe muscle fibers of the given muscle contract and the force ofcontraction is at its maximum level (in the absence of NMB). The levelof current required to achieve a supramaximal effect varies betweenindividual patients. Several factors including fluctuations in skinresistivity during a procedure, fat content, muscle mass, and musclecontractility, all may affect the current level necessary to achieve asupramaximal effect. Likewise, the voltage required to maintain thesupramaximal current at the same level varies in response to thevariations in resistance based on these factors. In one embodiment thesurgical system 10 therefore determines an optimum current (hereinafterreferred to as the “baseline current”) to be used for each individualpatient. In addition, the current output may be continually monitoredand the voltage output adjusted so as to maintain the selected baselinecurrent throughout the test.

FIG. 7 illustrates one manner in which the baseline current may bedetermined. A baseline-setting test is initiated at the beginning of thesurgical procedure, prior to the administration of any NMB. Astimulation pulse of the selected pulse width (preferably 200 μs) isdelivered at an initial current (typically 20 mA) and the contractionforce is measured and recorded by the system 10. A second pulse of thesame pulse width but increased current magnitude is then delivered andthe contraction force is again measured and recorded. This process maycontinue until the increase in current magnitude results in noadditional increase in contraction force. This current magnitude, whereno increase in contraction force occurs, may preferably be set as thebaseline current. In addition, the surgical system 10 may allow thebaseline to be set or reset manually at any time from the Twitch Testscreen (FIGS. 11-12) on the touch screen display 26, thereby providingthe surgeon or system operator with ultimate control over the baselinecurrent if needed. In one embodiment, the baseline current is manuallyset by selecting up and down control arrows 126 to either increase ordecrease the current level. This may be necessary, for example, if thebaseline-setting test was not performed before administration of an NMB.

In another embodiment, the baseline current used for the NMP test may besuch that it is slightly larger than the threshold current level(I_(Thresh)) at the time the NMP test is conducted. I_(thresh) is thelowest stimulation current necessary to evoke an EMG response with apeak-to-peak voltage (V_(pp)) greater than a predefined thresholdvoltage (V_(thresh)) which is typically around 100 μV. To determine thestimulation current level to employ for the NMP test, the surgicalsystem 10 may use a threshold-hunting algorithm to quickly andaccurately find I_(thresh). Preferably, upon selecting the Auto Detecttab 128, the system 10 detects I_(thresh) using a threshold-huntingalgorithm that applies bracketing and bisection methods which aredescribed in detail below. Once I_(thresh) has been determined thesurgical system 10 may display I_(thresh) for the user and/or select abaseline current that is greater than I_(thresh), which may similarly bedisplayed for the surgeon. According to one embodiment, set forth by wayof example only, this baseline current determination may be accomplishedby adding at least 1.0 mA to I_(thresh).

After setting a baseline current, the baseline current may subsequentlybe used any time the NMP test is conducted during a surgical procedure(i.e. prior to initiating the nerve monitoring tests, discussed indetail below) or a new baseline may be determined each time. Aspreviously mentioned, an exemplary NMP test consists of four 200 μselectrical impulses, delivered at a frequency of 2 Hz and at thedetermined baseline current. When the test is completed in the presenceof little or no NMB, the muscle activity pattern contains four clearlydefined muscle contractions of approximately the same amplitude,illustrated, by way of example only, in FIG. 8. As the NMB levelincreases, the contractions diminish in amplitude and disappear inreverse order beginning with the fourth contraction, illustrated, by wayof example only, in FIGS. 9-10.

According to one embodiment of the present invention, thesurgeon-directed surgical system 10 identifies a ratiometricrelationship between evoked responses to assess the status of the NMP.The amplitudes of each EMG response corresponding to the four electricalpulses (described above with reference to FIG. 6) are monitored andrecorded by the system 10. In one embodiment, the amplitude of the EMGresponse is defined by a peak-to-peak voltage of the response asdiscussed in more detail below. The value T1 equals the amplitude of thefirst muscle response, T2 is the amplitude of the second muscleresponse, T3 is the amplitude of the third response, and T4 is theamplitude of the fourth muscle response. Once values T1 through T4 aremeasured the system calculates the amplitude ratio between T4 and T1.The T4:T1 ratio provides an indication of the functioning capability ofthe NMP.

FIGS. 11-12 are exemplary screen displays, set forth by way of exampleonly, of one embodiment of the twitch test function. The T4:T1 ratio iscalculated and displayed to the user. In a preferred embodiment theT4:T1 ratio is displayed to the user in terms of the percentage of T4 toT1, as illustrated. In addition to the numerical result 120, the colorsRed, Yellow, and Green are preferably displayed to indicate to thesurgeon the level of safety determined by the system 10 during the NMPtest. By way of example only, the color red may be displayed when theT4:T1 ratio is determined to be below a predetermined alert level of, byway of example, 0.3 or 30%. Green may be displayed when the T4:T1 ratiois above the predetermined safe level, by way of example only 0.75 or75%. Finally, the color yellow may be displayed when the T4:T1 ratiofalls between the predetermined alert level and a predetermined safelevel (ie. between 30% and 75%). Also shown in FIG. 11-12 is a bar graph130 depicting the relative T1 through T4 response levels, which ispreferably displayed to the user along with the numerical result 120.FIG. 11 is an example of the twitch test display without the optionalEMG waveforms 116 and FIG. 12 shows the twitch test display with theoptional EMG waveforms 116 selected.

Although use of the system 10 for neuromuscular pathway assessment isshown and described above within the context of particular exemplarymethod of stimulation response analysis, it will be appreciated by thoseskilled in the art that a variety of methods may be employed by thesystem 10, for stimulating a nerve and analyzing the resultant muscleresponse or responses in order to determine the state of theneuromuscular pathway, and as such, fall within the scope of the presentinvention. These methods may include, but are not necessarily limited tothe all-or-none and single twitch techniques described below.

In an alternate embodiment, the disappearance of each responsecorresponds to particular level of NMB. By way of example only, thefourth contraction disappears at a 75% NMB level (meaning that 75% ofthe acetylcholine receptors are occupied), the third contractiondisappears at 80% NMB (meaning that 80% of the acetylcholine receptorsare occupied), the second disappears at 90% NMB (meaning that 90% of theacetylcholine receptors are occupied), and the first contractiondisappears at 100% NMB level (meaning that 100% of the acetylcholinereceptors are occupied). In one embodiment of the present invention,detection of an NMB level greater than 75%, (i.e. less than fourcontractions detected, corresponding to the four electrical impulses) asdepicted in FIG. 10, is considered an unsafe level. An acceptable NMBlevel of below 75% is indicated by an EMG response including all fourmuscle contractions (FIGS. 8-9). At this level of NMB, less than 75%, itis unlikely that a muscle will fail to contract in response tostimulation during the nerve monitoring tests.

In still another embodiment, the surgeon-directed surgical system 10 mayemploy a “single twitch” method for assessing the neuromuscular pathway.A baseline supramaximal current is again determined by the method setforth and described above. After determining the baseline and stillprior to the administration of NMB, a single 100 μs-300 μs (preferably200 μs) electrical pulse of the baseline current is delivered to thepatient via the surgical system 10 and the muscle response is measured.The amplitude of the measured response is the control value or T0 forsubsequent NMP tests. NMP tests are later initiated in the selected mode(Direct or Peripheral stimulation) with a single electrical impulseidentical to the pulse used to obtain T0 and the evoked muscle responseis measured. The measured amplitude of the response becomes T1. Thesystem 10 calculates the amplitude ratio between T0 and T1 (T1:T0) andcompares it to predetermined safe and unsafe levels. By way of exampleonly, when T1:T0 is greater than or equal to 0.9 (T1:T0≧0.9) the NMPtest is acceptable and the display 26 indicates the safe result. Whenthe T1:T0 ratio is less than 0.9 (T1:T0<0.9) the NMP is determined tounsafe (blocked) and the result is again indicated on the display 26,thereby alerting the surgeon to the unsafe NMP status.

While the NMP function has been described according to a preferredembodiment in which evoked muscle responses are detected using EMG, itis contemplated that other methods of detecting and measuring evokedresponses may also be employed. In an alternate embodiment, set forth byway of example only, the surgical system 10 may use pressure sensors(not shown) communicatively linked to the system, to monitor muscleactivity. An increase in pressure detected by the pressure sensorsdeployed over various muscles or myotomes indicates a muscle response.The magnitude of the response is reflected by the degree of pressurechange detected. The evoked responses may then be analyzed to identify arelationship between them according to one or more of the methodsdescribed above thereby providing an indication of the NMP status.

The surgeon-directed surgical system 10 is capable of performing pedicleintegrity tests, preferably after an NMP test has been conducted anddeemed acceptable and safe. This functionality includes a “Basic” screwtest and a “Dynamic Screw Test.” The basic, or static, screw testfunction is performing using screw test probe 36. The screw test probe36 is used to test the integrity of pedicle holes (during and/or afterformation) and/or screws (during and/or after introduction). The screwtest probe 36 includes a stimulation handpiece 34 and a probe member 38having a generally ball-tipped end 40. The handpiece 34 may be equippedwith one or more buttons for selectively applying the electricalstimulation to the ball-tipped end 40 at the end of the probe member 38.The ball tip 40 of the screw test probe 36 is placed in the screw holeprior to screw insertion or placed on the installed screw head. Theinsulating character of bone will prevent the stimulation current, up toa certain amplitude, from communicating with the nerve. However, in theevent the pedicle wall has been breached by the screw or tap, thestimulation current will pass through to the adjacent nerve roots andthey will depolarize at a lower stimulation current.

The “Dynamic” screw test function may use at least one of an electriccoupling device 42 and 52. The probe member 38 and the ball-tipped end40 of screw test probe 36 may be removed from the stimulation handpiece34 and replaced with an electric coupling device 42, 52. The electriccoupling devices 42, 52 may be utilized to couple a surgical instrument,such as for example only, a tap member 72, pedicle access probe 74, orother similar instrument, to the surgical system 10. By this means, astimulation signal may be passed through the surgical instrument andscrew testing can be performed while the tool is in use. Thus, screwtesting may be performed during pilot hole formation by coupling the tapmember 72 or pedicle probe 74 to the surgical system 10. Likewise, bycoupling a pedicle screw to the surgical system 10, screw testing may beperformed during screw introduction.

The electric coupling device may comprise a number of possibleembodiments which permit the device to attach and hold a surgicalinstrument while allowing transmission of a stimulation signal to thetool. One such electric coupling device 42 utilizes a spring-loadedplunger to hold the surgical tool and transmit the stimulation signal.The plunger 44 is composed of a conductive material such as metal. Anonconductive housing 46 partially encases the plunger 44 about itscenter. Extending from the housing 46 is an end plate 48. An electricalcable 50 connects the electric coupling device 42 to the stimulationhandpiece 34. A spring (not shown) is disposed within the housing 46such that in a natural or “closed” state the plunger 44 is situated inclose proximity to the endplate 42. Exerting a compressive force on thespring (such as by pulling the cable 50 while holding the housing 46)causes a gap between the end plate 48 and the plunger 44 to widen to an“open” position, thereby allowing insertion of a surgical tool betweenthe end plate 48 and plunger 44. Releasing the cable 50 allows thespring to return to a “closed” position, causing the plunger 44 to movelaterally back towards the endplate such that a force is exerted uponthe surgical instrument and thereby holds it in place between theendplate 48 and the plunger 44. Thereafter the electrical stimulus maybe passed from the handpiece 34 through the cable 50 and plunger 44 tothe surgical instrument.

Alternatively, the electrical coupling device may be embodied in theform of a clip 52. The clip 52 is comprised of two prongs hingedlycoupled at a coupling point 54 such that the clip 52 includes anattachment end 56 and a non-attachment end 58. A stimulation electrode60 is disposed on the attachment end 56 and communicates with electriccable 50 extending from the non-attachment end 56 to the handle 34. In a“closed” position the prong ends at the attachment end 56 touch.Depressing the prongs at the non-attachment end 58 in a directiontowards each other causes a gap to form between the prong ends at theattachment end 56. Positioning the “opened” attachment end 56 over adesired surgical instrument and releasing the force on thenon-attachment end 58 causes the attachment end 56 to pinch tight on thesurgical instrument and thereby allow the electrical stimulus to passfrom the screw test handle 34, through the stimulation electrode 60, tothe surgical instrument.

FIG. 13 depicts an exemplary setup screen for the screw test functions.From the setup screen the user may select to have stimulation signalsstop on the first response or to continue until a maximum current levelis reached. The maximum stimulation current may also be changed usingthe “up” and “down” control arrows 126 to increase or decrease thecurrent level. In addition, the user may turn different EMG channels onor off, set the date and time, conduct an impedance test to check theelectrical connection between the EMG electrodes and the patient's skin,and shutdown the system 10.

Upon pressing the button on the stimulation handpiece 34, the softwarewill execute an algorithm (discussed below) that results in all channeltabs 132 being color-coded to indicate the detection status of thecorresponding nerve. The algorithm preferably determines thedepolarization (stimulation threshold current, I_(thresh)) current forall 8 EMG channels. The channel with the “worst” (lowest I_(thresh))level will be highlighted (enlarged) and that myotome name will bedisplayed 102, as well as graphically depicted on the spine diagram 100and the numerical stimulation result (I_(thresh)) 120 for that channelis displayed, as illustrated in FIGS. 14-19. EMG channel tabs 132 mayalso be selected via the touch screen display 26 to show the I_(thresh)of the corresponding nerves. A vertical stimulation bar chart 112 isshown, to depict the stimulation current required for nervedepolarization in mA for the selected channel. The handpiece 34 may beequipped with a mechanism (via hardware and/or software) to identifyitself to the system when it is attached. In one embodiment, the probemember 38 is disposable and the handpiece 34 is reusable andautoclavable.

FIGS. 14-15 depict screen displays, shown by way of example only, forthe Basic Screw Test function, one without optional EMG waveforms 116(FIG. 14) and one with the optional EMG waveforms 116 (FIG. 15). FIGS.16-17 depict screen displays shown by way of example only, for theDynamic Screw Test function, again, one without optional EMG waveforms116 (FIG. 16) and one with the optional EMG waveforms 116 (FIG. 17).Finally, FIGS. 18-19 depict screen displays, shown by way of exampleonly, for the Difference Screw Test function, one without optional EMGwaveforms 116 (FIG. 18) and one with the optional EMG waveforms 116(FIG. 19). For the Difference Screw Test, the surgeon sets a baselinethreshold 134 current by stimulating a nerve root directly with thescrew test probe 36. The actual threshold current 136 is then determinedand displayed relative to the baseline providing a difference threshold138. In one embodiment, the stimulation result is displayed to thesurgeon along with a color code so that the surgeon may easilycomprehend the situation and avoid neurological impairment to thepatient. The colors Red, Yellow, and Green are preferably displayed toindicate to the surgeon the level of safety determined by the system 10.Red is used to indicate an I_(thresh) level below a predetermined unsafelevel. Yellow indicates an I_(thresh) that falls in betweenpredetermined safe and unsafe levels. Green represents an I_(thresh)within the range predetermined as safe. By way of example only, a greendisplay denotes a stimulation threshold range of 9 milliamps (mA) orgreater, a yellow display denotes a stimulation threshold range of 6-8mA, and a red display denotes a stimulation threshold range of 6 mA orbelow.

The surgeon-directed surgical system 10 may provide safe andreproducible access to a surgical target site by detecting the existenceof (and optionally the distance) neural structures before, during, andafter the establishment of an operative corridor through (or near) anyof a variety of tissues having such neural structures which, ifcontacted or impinged, may otherwise result in neural impairment for thepatient. The surgical system 10 does so, preferably after an acceptableNMP test has been completed, by electrically stimulating nerves via oneor more stimulation electrodes at the distal end of the surgical accesscomponents 62-66 while monitoring the EMG responses of the muscle groupsinnervated by the nerves. In a preferred embodiment the accesscomponents are coupled to the surgical system 10 using electricalcoupling device 42 or 52 in the same manner described above.Alternatively, a stimulator driver 68 is provided to electrically couplethe surgical access components 62-66 to the patient module 14 (viaaccessory cable 30). The stimulator driver 68 preferably includes one ormore buttons for selectively activating the stimulation current and/ordirecting it to a particular surgical access component.

The surgical access components 62-66 (FIG. 1) are designed to bluntlydissect the tissue between the patient's skin and the surgical targetsite. An initial dilating cannula 64 is advanced towards the targetsite, preferably after having been aligned using any number ofcommercially available surgical guide frames. An obturator (not shown)may be included inside the initial dilator 64 and may similarly beequipped with one or more stimulating electrodes. Once the properlocation is achieved, the obturator (not shown) may be removed and theK-wire 62 inserted down the center of the initial dilating cannula 64and docked to the given surgical target site, such as the annulus of anintervertebral disc. Cannulae of increasing diameter are then guidedover the previously installed cannula 64 until the desired lumen isinstalled. By way of example only, the dilating cannulae 64 may range indiameter from 6 mm to 30 mm. The working cannula 66 is installed overthe last dilating cannula 64 and then all the dilating cannulae 64 areremoved from inside the inner lumen of the working cannula 66 toestablish the operative corridor therethrough.

Additional and/or alternative surgical access components such as, by wayof example only, a tissue retraction assembly 70 (FIG. 1) may be coupledto the system 10 and employed to provide safe and reproducible access toa surgical target site. Tissue retraction assembly 70 and variousembodiments and uses thereof have been shown and described in the abovereferenced co-pending and commonly assigned U.S. patent application Ser.No. 10/967,668, entitled “Surgical Access System and Related Methods,”filed on Oct. 18, 2004, the entire contents of which are expresslyincorporated by reference as if set forth herein in their entirety.

FIG. 20 depicts, by way of example only, a setup screen for nervedetection. Using this screen the operator may change the maximumstimulation current using up and down control arrows 126 to increase ordecrease the current level, turn different EMG channels on or off, setthe date and time, conduct an impedance test to check the electricalconnection between the EMG electrodes and the patients skin, andshutdown the system 10. FIGS. 21-22 depict exemplary screen displays ofthe detection function. The function indicator tab 110 indicates thatdetection is the selected function. The EMG channel possessing thelowest stimulation result 120 may be automatically highlighted and/orcolored to clearly indicate this fact to the surgeon. Additionally, EMGchannel tabs 132 may be selected via the touch screen display 26 to showthe result 120 of the corresponding nerves. As with the NMP and ScrewTests, the stimulation results are displayed to the surgeon with theRed, Yellow, Green color code wherein Red, Yellow, and Green arepreferably displayed to indicate to the surgeon the level of safetydetermined by the system 10. In one embodiment of nerve detection, setforth by way of example only, a green display corresponds to astimulation threshold range of 10 milliamps (mA) or greater, a yellowdisplay denotes a stimulation threshold range of 5-9 mA, and a reddisplay denotes a stimulation threshold range of 4 mA or below. FIG. 21illustrates the detection function without EMG waveforms 116 and FIG. 22illustrates the detection function with the EMG waveforms 116 displayed.

The surgical system 10 accomplishes neural pathology monitoring,preferably after conducting a neuromuscular pathway test, byelectrically stimulating a retracted nerve root via one or morestimulation electrodes at the distal end of the nerve root retractor 76while monitoring the EMG responses of the muscle group innervated by theparticular nerve. The EMG responses provide a quantitative measure ofthe nerve depolarization caused by the electrical stimulus. Analysis ofthe EMG responses may then be used to assess the degree to whichretraction of a nerve or neural structure affects the nerve functionover time, as will be described with greater particularity below. Oneadvantage of such monitoring, by way of example only, is that theconduction of the nerve may be monitored during the procedure todetermine whether the neurophysiology and/or function of the nervechanges (for the better or worse) as the result of the particularsurgical procedure. For example, it may be observed that the nerveconduction increases as the result of the operation, indicating that thepreviously inhibited nerve has been positively affected by theoperation. The nerve root retractor 76 (FIG. 1) may comprise any numberof suitable devices capable of maintaining contact with a nerve or nerveroot. The nerve root retractor 76 may be dimensioned in any number ofdifferent fashions, including having a generally curved distal region(shown as a side view in FIG. 1 to illustrate the concave region wherethe nerve will be positioned while retracted), and of sufficientdimension (width and/or length) and rigidity to maintain the retractednerve in a desired position during surgery. The nerve root retractor 76may also be equipped with a stimulation handle 78 (similar to thestimulation handpiece 34 described above) having one or more buttons forselectively applying the electrical stimulation to the stimulationelectrode(s) at the end of the nerve root retractor 76. In oneembodiment, the nerve root retractor 76 is disposable and thestimulation handle 78 is reusable and autoclavable.

In a preferred embodiment, nerve pathology is monitored via the NerveRetractor function specifically by determining a baseline stimulationthreshold with direct contact between the nerve retractor 76 and thenerve but prior to retraction. Subsequently, additional stimulationthresholds are determined during retraction and they are compared to thebaseline threshold. Significant changes in the stimulation threshold mayindicate potential trauma to the nerve caused by the retraction. Theinformation regarding nerve pathology is conveyed to the surgeon via thenerve retractor screen display, shown by way of example only in FIG. 24.The function indicator 110 shows that Nerve Retractor is the activefunction and stimulation bar 112 graphically depicts the stimulationcurrent level. A channel window 144 is provided for each EMG channel.Included in the channel window is information including the channelnumber, myotome name and associated spinal level, the EMG waveform 116,the baseline threshold, current detected threshold, and the previousdetected threshold. Site selection buttons 146 allow the surgeon toquickly annotate a threshold response with the spinal level stimulated.The EMG sensitivity and Free-Run status are also displayed 148 on thescreen. In the event the system 10 detects a significant differencebetween the baseline threshold and the current threshold on a particularchannel, the associated channel window may preferably be highlighted toindicate the potential danger to the surgeon. The maximum allowablestimulation currents for both the baseline and retractor stimulationsmay be set or changed manually using the up and down control arrows 126on the nerve retractor setup screen, shown by way of example only inFIG. 23. In addition the user may turn different channels on or off, setthe date and time, conduct an impedance test to check the electricalconnection between the EMG electrodes and the patient's skin, andshutdown the system 10, all from the same setup screen.

The nerve testing functions mentioned above (screw test, nerveproximity, nerve pathology) are based on assessing the evoked responseof the various muscles myotomes monitored by the surgical system 10,preferably via the EMG electrodes 18. This is best shown in FIG. 25-26,wherein FIG. 25 illustrates the EMG of a monitored myotome to thestimulation current pulse shown in FIG. 26. The EMG response can becharacterized by a peak-to-peak voltage of V_(pp)=V_(max)−V_(min). Thestimulation current may be coupled in any suitable fashion (i.e. AC orDC) and comprises monophasic pulses of 200 μs duration, with anamplitude and frequency that is controlled and adjusted by the software.For each nerve and myotome there is a characteristic delay from thestimulation current pulse to the EMG response (typically between 5 to 20ms). To account for this, the frequency of the current pulses is set ata suitable level such as, in a preferred embodiment, 4 Hz to 10 Hz (andmost preferably 4.5 Hz), so as to prevent stimulating the nerve beforeit has a chance to recover from depolarization.

FIG. 27 illustrates an alternate manner of setting the maximumstimulation frequency (F_(max)), to the extent it is desired to do sorather than simply selecting a fixed maximum stimulation frequency (suchas 4.5 Hz) as described above. According to this embodiment, the maximumfrequency of the stimulation pulses is automatically adjusted. Aftereach stimulation, F_(max) will be computed as:F_(max)=1/(T2+T_(Safety Margin)) for the largest value of T2 from eachof the active EMG channels. In one embodiment, the Safety Margin is 5ms, although it is contemplated that this could be varied according toany number of suitable durations. Before the specified number ofstimulations, the stimulations will be performed at intervals of 100-120ms during the bracketing state, intervals of 200-240 ms during thebisection state, and intervals of 400-480 ms during the monitoring state(bracketing, bisection and monitoring states are discussed in detailbelow). After the specified number of stimulations, the stimulationswill be performed at the fastest interval practical (but no faster thanF_(max)) during the bracketing state, the fastest interval practical(but no faster than F_(max)/2) during the bisection state, and thefastest interval practical (but no faster than F_(max)/4) during themonitoring state. The maximum frequency used until F_(max) is calculatedis preferably 10 Hz, although slower stimulation frequencies may be usedduring some acquisition algorithms. The value of F_(max) used isperiodically updated to ensure that it is still appropriate. Forphysiological reasons, the maximum frequency for stimulation will be seton a per-patient basis. Readings will be taken from all myotomes and theone with the slowest frequency (highest T2) will be recorded.

A basic premise behind the neurophysiology employed for nerve testing inthe present invention is that each nerve has a characteristic thresholdcurrent level (I_(Thresh)) at which it will depolarize. Below thisthreshold, current stimulation will not evoke a significant EMG response(V_(pp)). Consequently, it is this premise that makes NMP testing avaluable step in nerve testing because I_(thresh) may be significantlyaltered in the presence of high levels of NMB. Once the stimulationthreshold (I_(Thresh)) is reached, the evoked response is reproducibleand increases with increasing stimulation until saturation is reached asshown in FIG. 28. This is known as a “recruitment curve.” In oneembodiment, a significant EMG response is defined to have a V_(pp) ofapproximately 100 uV. The lowest stimulation current that evokes thisthreshold voltage (V_(Thresh)) is called I_(Thresh). I_(thresh)decreases as the degree of electrical communication between astimulation impulse and a nerve increases. Thus, monitoring I_(thresh),can provide the surgeon with useful information. For example, obtaininga lower than expected I_(thresh) when applying a stimulation impulse tothe tip of a pedicle screw (or the interior of a pilot hole) mayindicate electrical communication between the stimulation element andthe nerve, such communication being indicative of a breach in thepedicle. Monitoring I_(thresh) may also be employed to provide thesurgeon with a relative indication of distance from the stimulationelectrode to a nerve.

In order to obtain I_(thresh) and take advantage of the usefulinformation it provides, the peak-to-peak voltage (V_(pp)) of each EMGresponse corresponding a given stimulation current (I_(Stim)) must beidentified. This may be complicated by the existence of stimulationand/or noise artifacts which may create an erroneous V_(pp) measurementof the electrically evoked EMG response. To overcome this challenge, thesurgical system 10 of the present invention may employ any number ofsuitable artifact rejection techniques such as those shown and describedin full in the above referenced PCT App. Ser. No. PCT/US2004/025550,entitled “System and Methods for Performing Dynamic Pedicle IntegrityAssessments,” filed on Aug. 5, 2004, the contents of which are herebyincorporated by reference into this disclosure as if set forth herein intheir entireties.

Having measured each V_(pp) EMG response, the V_(pp) information isanalyzed relative to the stimulation current in order to determine arelationship between the nerve and the given stimulation elementtransmitting the stimulation current. More specifically, the presentinvention determines these relationships (between nerve and thestimulation element) by identifying the minimum stimulation current(I_(thresh)) capable of resulting in a predetermined V_(pp) EMGresponse. According to the present invention, the determination ofI_(Thresh) may be accomplished via any of a variety of suitablealgorithms or techniques.

FIGS. 29A-29D illustrate, by way of example only, a threshold-huntingalgorithm that employs a series of monopolar electrical stimulations todetermine the stimulation current threshold I_(thresh) for each EMGchannel in range. The nerve is stimulated using current pulses withamplitude of I_(stim). The muscle groups respond with an evokedpotential that has a peak-to-peak voltage of V_(pp). The object of thisalgorithm is to quickly find I_(Thresh), which once again, is theminimum I_(stim) that results in a V_(pp) that is greater than a knownthreshold voltage V_(thresh). The value of I_(stim) is adjusted by abracketing method as follows. The first bracket is 0.2 mA and 0.3 mA. Ifthe V_(pp) corresponding to both of these stimulation currents is lowerthan V_(thresh), then the bracket size is doubled to 0.2 mA and 0.4 mA.This exponential doubling of the bracket size continues until the upperend of the bracket results in a V_(pp) that is above V_(thresh). Thesize of the brackets is then reduced by a bisection method. A currentstimulation value at the midpoint of the bracket is used and if thisresults in a V_(pp) that is above V_(thresh), then the lower halfbecomes the new bracket. Likewise, if the midpoint V_(pp) is belowV_(thresh) then the upper half becomes the new bracket. This bisectionmethod is used until the bracket size has been reduced to Ires mA.I_(Thresh) is the value of I_(stim) that is the higher end of thebracket.

The threshold hunting will support three states: bracketing, bisection,and monitoring. A stimulation current bracket is a range of stimulationcurrents that bracket the stimulation current threshold I_(Thresh). Theupper and/or lower boundaries of a bracket may be indeterminate. Thewidth of a bracket is the upper boundary value minus the lower boundaryvalue. If the stimulation current threshold I_(Thresh) of a channelexceeds the maximum stimulation current, that threshold is consideredout-of-range. During the bracketing state, threshold hunting will employthe method below to select stimulation currents and identify stimulationcurrent brackets for each EMG channel in range.

The method for finding the minimum stimulation current uses the methodsof bracketing and bisection. The “root” is identified for a functionthat has the value −1 for stimulation currents that do not evokeadequate response; the function has the value +1 for stimulationcurrents that evoke a response. The root occurs when the function jumpsfrom −1 to +1 as stimulation current is increased: the function neverhas the value of precisely zero. The root will not be known precisely,but only with some level of accuracy. The root is found by identifying arange that must contain the root. The upper bound of this range is thelowest stimulation current I_(Thresh) where the function returns thevalue +1 (i.e. the minimum stimulation current that evokes response).

Both the screw test function and the proximity function, as well as theoptional NMP baseline setting method utilizing I_(thresh) (describedabove), begin by adjusting the stimulation current from the surgicalaccessory until the root is bracketed (FIG. 29B). The initial bracketingrange may be provided in any number of suitable ranges. In oneembodiment, the initial bracketing range is 0.2 to 0.3 mA. If the upperstimulation current does not evoke a response, the upper end of therange should be increased. The range scale factor is 2. The stimulationcurrent should never be increased by more than 10 mA in one iteration.The stimulation current should never exceed the programmed maximumstimulation current. For each stimulation, the algorithm will examinethe response of each active channel to determine whether it falls withinthat bracket. Once the stimulation current threshold of each channel hasbeen bracketed, the algorithm transitions to the bisection state.

During the bisection state (FIG. 29C), threshold hunting will employ themethod described below to select stimulation currents and narrow thebracket to a width of 0.1 mA for each EMG channel with an in-rangethreshold. After the minimum stimulation current has been bracketed(FIG. 29C), the range containing the root is refined until the root isknown with a specified accuracy. The bisection method is used to refinethe range containing the root. In one embodiment, the root should befound to a precision of 0.1 mA. During the bisection method, thestimulation current at the midpoint of the bracket is used. If thestimulation evokes a response, the bracket shrinks to the lower half ofthe previous range. If the stimulation fails to evoke a response, thebracket shrinks to the upper half of the previous range. The algorithmis locked on the electrode position when the response threshold isbracketed by stimulation currents separated by 0.1 mA. The process isrepeated for each of the active channels until all thresholds areprecisely known. At that time, the algorithm enters the monitoringstate.

During the monitoring state (FIG. 29D), threshold hunting will employthe method described below to select stimulation currents and identifywhether stimulation current thresholds are changing. In the monitoringstate, the stimulation current level is decremented or incremented by0.1 mA, depending on the response of a specific channel. If thethreshold has not changed then the lower end of the bracket should notevoke a response, while the upper end of the bracket should. If eitherof these conditions fail, the bracket is adjusted accordingly. Theprocess is repeated for each of the active channels to continue toassure that each threshold is bracketed. If stimulations fail to evokethe expected response three times in a row, then the algorithmtransitions back to the bracketing state in order to reestablish thebracket.

When it is necessary to determine the stimulation current thresholds(I_(thresh)) for more than one channel, they may be obtained bytime-multiplexing the threshold-hunting algorithm as shown in FIG. 30.During the bracketing state, the algorithm will start with a stimulationcurrent bracket of 0.2 mA and increase the size of the bracketexponentially. With each bracket, the algorithm will measure the V_(pp)of all channels to determine which bracket they fall into. After thisfirst pass, the algorithm will know which exponential bracket containsthe I_(thresh) for each channel. Next, during the bisection state, thealgorithm will start with the lowest exponential bracket that containsan I_(thresh) and bisect it until I_(thresh) is found within 0.1 mA. Ifthere are more than one I_(thresh) within an exponential bracket, theywill be separated out during the bisection process, and the one with thelowest value will be found first. During the monitoring state, thealgorithm will monitor the upper and lower boundaries of the bracketsfor each I_(thresh), starting with the lowest. If the I_(thresh) for oneor more channels is not found in it's bracket, then the algorithm goesback to the bracketing state to re-establish the bracket for thosechannels.

Insertion and advancement of the access instruments 62-66, 70 should beperformed at a rate sufficiently slow to allow the surgical system 10 toprovide real-time indication of the presence of nerves that may lie inthe path of the tip. To facilitate this, the threshold currentI_(Thresh) may be displayed such that it will indicate when thecomputation is finished and the data is accurate. For example, when thedetection information is up to date and the instrument such that it isnow ready to be advanced by the surgeon, it is contemplated to have thecolor display show up as saturated to communicate this fact to thesurgeon. During advancement of the instrument, if a channel's colorrange changes from green to yellow, advancement should proceed moreslowly, with careful observation of the detection level. If the channelcolor stays yellow or turns green after further advancement, it is apossible indication that the instrument tip has passed, and is movingfarther away from the nerve. If after further advancement, however, thechannel color turns red, then it is a possible indication that theinstrument tip has moved closer to a nerve. At this point the displaywill show the value of the stimulation current threshold in mA. Furtheradvancement should be attempted only with extreme caution, whileobserving the threshold values, and only if the surgeon deems it safe.If the surgeon decides to advance the instrument tip further, anincrease in threshold value (e.g. from 3 mA to 4 mA) may indicate theinstrument tip has safely passed the nerve. It may also be an indicationthat the instrument tip has encountered and is compressing the nerve.The latter may be detected by listening for sporadic outbursts, or“pops”, of nerve activity on a free running EMG audio output (asmentioned below). If, upon further advancement of the instrument, thealarm level decreases (e.g., from 4 mA to 3 mA), then it is very likelythat the instrument tip is extremely close to the spinal nerve, and toavoid neural damage, extreme caution should be exercised during furthermanipulation of the instrument. Under such circumstances, the decisionto withdraw, reposition, or otherwise maneuver the instrument is at thesole discretion of the clinician based upon available information andexperience. Further radiographic imaging may be deemed appropriate toestablish the best course of action.

As noted above, the surgical system 10 accomplishes neural pathologymonitoring by electrically stimulating a retracted nerve root via one ormore stimulation electrodes at the distal end of the nerve rootretractor 76 while monitoring the EMG responses of the muscle groupinnervated by the particular nerve. FIG. 31 shows the differencesbetween a healthy nerve (A) and a pathologic or unhealthy nerve (B). Theinventors have found through experimentation that information regardingnerve pathology (or “health” of “status”) can be extracted from therecruitment curves generated according to the present invention (see,e.g., discussion accompanying FIGS. 25-28). In particular, it has beenfound that a healthy nerve or nerve bundle will produce a recruitmentcurve having a generally low threshold or “hanging point” (in terms ofboth the y-axis or V_(pp) value and the x-axis or I_(Stim) value), alinear region having a relatively steep slope, and a relatively highsaturation region (similar to those shown on recruitment curve “A” inFIG. 31). On the contrary, a nerve or nerve bundle that is unhealthy orwhose function is otherwise compromised or impaired (such as beingimpinged by spinal structures or by prolonged retraction) will producerecruitment curve having a generally higher threshold (again, in termsof both the y-axis or V_(pp) value and the x-axis or I_(Stim) value), alinear region of reduced slope, and a relatively low saturation region(similar to those shown on recruitment curve “B” in FIG. 31). Byrecognizing these characteristics, one can monitor nerve root beingretracted during a procedure to determine if its pathology or health isaffected (i.e. negatively) by such retraction. Moreover, one can monitora nerve root that has already been deemed pathologic or unhealthy beforethe procedure (such as may be caused by being impinged by bonystructures or a bulging annulus) to determine if its pathology or healthis affected (i.e. positively) by the procedure.

In addition to the directed nerve testing functions described above, thesurgical system 10 also preferably performs passive monitoring via freerun EMG conducted continuously from the EMG electrodes 18 when otherfunctions are not active. In doing so, the operating user may be alertedto any nerve activity occurring unexpectedly. An audio pick-up (notshown) may also be provided as an optional feature according to thepresent invention. In some cases, when a nerve is stretched orcompressed, it will emit a burst or train of spontaneous nerve activity.The audio pick-up is capable of transmitting sounds representative ofsuch activity such that the surgeon can monitor this response on audioto help him determine if there has been stress to the nerve.

To facilitate record keeping, results from the various functionsdescribed above are preferably saved by the system 10 throughout thesurgical procedure and a report may be generated containing all of thestimulation results. To enhance the clarity and usefulness of thereported data the surgical system 10 provides a method for quickly andeasily annotating each stimulation result with additional relevantinformation including, but not necessarily limited to, the side andlevel where the stimulation occurred as well as the structure stimulated(e.g. nerve, screw, or pilot hole). FIGS. 32A-32E illustrate one methodof annotating stimulation responses according to a preferred embodimentof the present invention. With reference to FIG. 32A a sequence bar 114may be included on the various result screens described above. Thesequence bar may preferably display up to the last seven stimulationresults in chronological order beginning with the most recent result.Annotations may be added to any or all of the results by selecting thedesired result using the GUI display 26. The selected result will appearon the screen along with a time indicator 140 showing the precise timeat which the result was obtained. Again using the GUI display 26 atleast one of the side, spinal level, and structure stimulated may beselected, as shown in FIGS. 32B, 32C, and 32C, respectively. Theannotated data is saved along with the stimulation result 120 and may bereproduced in a subsequent surgical report. Annotated results maypreferably be demarcated with a suitable icon 142 representing that itincludes annotated information, as shown in FIG. 32E. It should beunderstood that although the annotation feature is demonstrated withrespect to the screw test function, stimulation results for all of thefunctions described may be annotated using this method.

With reference to FIG. 33, the stimulation results, includingannotations, may be compiled in a surgical report chronicling all nervemonitoring functions conducted during the procedure. In one embodiment,the report may be printed immediately from one or more printers locatedin the operating room or copied to any of a variety of memory devicesknown in the prior art, such as, by way of example only, a floppy disk,USB memory stick and/or transferred via infrared transmission technologyto a handheld device such as a personal digital assistant (PDA). Thesystem 10 may generate either a full report or a summary reportdepending the particular needs of the user, who may select one or bothusing the GUI screen display 26, as illustrated in FIG. 34. FIGS.35A-35C are an exemplary representation of a summary report generated bysystem 10. The summary report includes space for patient, physician, andprocedural information and surgeon operative notes along with thestimulation results. The stimulation results, including any annotateddata, are preferably displayed in chronological order for each function.FIGS. 36A-36E are an exemplary representation of a full report generatedby the system 10. The full report also includes space for patient andphysician information and surgeon operative notes. The full stimulationresults are displayed in chronological order regardless of theparticular function.

The control unit 12 is configured to monitor the system statusthroughout its use. In the event the control unit 12 detects anaberration, an error log is created in which the details of the errorare described and stored to assist in later troubleshooting and systemcorrection. To service the system 10, the error logs may be accesseddirectly from the control unit 12 hardware and software. In addition,error logs may be downloaded onto any of a number of suitable media tofacilitate data transfer between remote locations. By way of exampleonly, the error logs may be downloaded to a USB memory device, floppydisk, CD, or DVD. By way of further example, the error logs may bedownloaded onto a network and transmitted to remote locations via theInternet or other data transfer systems.

The surgeon-directed surgical system 10 of the present inventionovercomes the drawbacks of the prior art and answers the previouslyunmet need in the prior art. The surgical system 10 boasts a number oftechniques for performing neuromuscular pathway testing prior to nervetesting, such as pedicle integrity testing, nerve detection, and nervepathology assessment, which advantageously minimizes the likelihood thatthe surgeon will obtain false positive assessments when performing suchnerve testing procedures. Moreover, the surgical system 10 is capable ofbeing controlled and interpreted by a surgeon without the assistance ofa neurophysiologist (hence the term “surgeon-directed”). The complextask of EMG analysis is performed by the reliable and objectiveprocessing techniques of the present invention, which eliminates or atleast reduces the potential for human error that is present withneurophysiologists. The surgeon-directed system 10 is quickly conveysthe information in a straightforward and easy to understand (yetmeaningful) manner, and does so under the command of the surgeon basedon their immediate need (saving valuable surgery time). It also reducesthe challenges involved in scheduling a neurophysiologist to assist withthe surgery, as well as avoids the issue of making a patient wait (inpain) while the schedules of the surgeon and neurophysiologist coincide.Finally, the surgeon-directed system 10 combines the functionalcapability to perform nerve monitoring functions and the ability toensure the safety and accuracy of those functions by assessing theneuromuscular pathway together in one easy to use, surgeon-directedsystem.

The surgical system 10 and related methods have been described aboveaccording to one embodiment of the present invention. It will be readilyappreciated that various modifications may be undertaken, or certainsteps or algorithms omitted or substituted, without departing from thescope of the present invention. By way of example only, certain of thesealternate embodiments or methods will be described below. Moreover,although described with reference to the surgical system 10, it willparticularly be appreciated as within the scope of the invention toperform the neuromuscular pathway test described herein with any numberof different neurophysiology based testing systems.

While this invention has been described in terms of a best mode forachieving this invention's objectives, it will be appreciated by thoseskilled in the art that variations may be accomplished in view of theseteachings without deviating from the spirit or scope of the presentinvention. For example, the present invention may be implemented usingany combination of computer programming software, firmware or hardware.As a preparatory step to practicing the invention or constructing anapparatus according to the invention, the computer programming code(whether software or firmware) according to the invention will typicallybe stored in one or more machine readable storage mediums such as fixed(hard) drives, diskettes, optical disks, magnetic tape, semiconductormemories such as ROMs, PROMs, etc., thereby making an article ofmanufacture in accordance with the invention. The article of manufacturecontaining the computer programming code is used by either executing thecode directly from the storage device, by copying the code from thestorage device into another storage device such as a hard disk, RAM,etc. or by transmitting the code on a network for remote execution. Ascan be envisioned by one of skill in the art, many differentcombinations of the above may be used and accordingly the presentinvention is not limited by the specified scope.

What is claimed is:
 1. A surgical system for performing nerve testingduring at least a portion of a surgical procedure, comprising: anaccessory configured to transmit a stimulation signal to a nerve formingpart of a neuromuscular pathway including a muscle myotome associatedwith the nerve; a sensor configured to detect evoked responses from themuscle myotome; and a control unit coupled to the accessory and thesensor, the control unit being operable to (a) transmit via an accessorya stimulation signal to a nerve forming part of the neuromuscularpathway including a muscle associated with the nerve, (b) monitor theevoked responses from a sensor associated with the muscle, (c) assessthe neuromuscular pathway by identifying a relationship between themagnitude of at least two evoked responses, wherein the relationshipprovides an indication as to a level of a neuromuscular blockade withina patient's body prior to or during said nerve testing, and furtherwherein said nerve testing includes at least one of static pedicleintegrity testing, dynamic pedicle integrity testing, nerve detectionduring surgical access, and nerve root retraction.
 2. The surgicalsystem of claim 1, wherein the relationship identified is the ratiobetween the magnitude of a first evoked response and a second evokedresponse.
 3. The surgical system of claim 1, wherein the relationshipidentified is at least one of the presence and absence of the secondevoked response.
 4. The surgical system of claim 2, wherein the sensoris configured to detect an EMG voltage output of the muscle myotome andthe control unit determines the magnitude of said EMG voltage output tocharacterize the evoked response.
 5. The surgical system of claim 4,wherein the magnitude of the voltage output is characterized by apeak-to-peak amplitude.
 6. The surgical system of claim 4, wherein therelationship identified is the ratio of the amplitude of the secondevoked response versus the amplitude of the first evoked response. 7.The surgical system of claim 4, wherein the stimulation signal comprisesfour electric current pulses of equal magnitude and the relationship isthe amplitude ratio of a fourth evoked response versus the amplitude ofa first response.
 8. The surgical system of claim 1, wherein the systemassesses the neuromuscular pathway prior to a nerve testing during atleast one of cervical, thoracic and lumbar spine surgery.
 9. Thesurgical system of claim 1, wherein the system assesses theneuromuscular pathway by applying the stimulation signal at least one ofon or near the nerve.
 10. The surgical system of claim 1, wherein thesystem assesses the neuromuscular pathway by applying the stimulationsignal to electrodes adapted to be placed over a peripheral nerve. 11.The surgical system of claim 1, wherein the stimulation signal includesat least two current pulses, each having a pulse duration and a deliveryfrequency.
 12. The surgical system of claim 11, wherein the pulseduration is the range from 100 to 500 microseconds, and further whereinthe delivery frequency of each pulse is in the range from 0.5 Hz to 5Hz.
 13. The surgical system of claim 11, wherein the amplitude of thecurrent pulses is determined by assessing the threshold current requiredto obtain an evoked response.
 14. The surgical system of claim 1,wherein the system assesses the neuromuscular pathway via an assessmentthat includes establishing a baseline current prior to theadministration of a neuromuscular blocking agent.
 15. The surgicalsystem of claim 11, wherein the stimulation signal includes four currentpulses.
 16. The surgical system of claim 1, wherein the control unit isfurther configured to display at least one of alpha-numeric or graphicalinformation regarding at least one of the stimulation signal, theneuromuscular responses, and the status of the neuromuscular pathway.17. The surgical system of claim 1, wherein the sensor is configured todetect changes in pressure and the magnitude of the evoke responses ischaracterized by the measured pressure change.
 18. The surgical systemof claim 1, wherein the stimulation signal comprises four electricalcurrent pulses of equal amplitude resulting in four corresponding evokedresponses and the relationship identified is the ratio of thepeak-to-peak amplitude of the fourth evoked response relative to thepeak-to-peak amplitude of the first evoked response.
 19. The surgicalsystem of claim 1, wherein the stimulation signal comprises oneelectrical current pulse and the control unit calculates the ratio ofthe peak-to-peak amplitude of a first evoked response relativepeak-to-peak amplitude of a predetermined baseline response.
 20. Thesurgical system of claim 18, wherein the control unit is furtherconfigured to display at least one of a numerical value representing theamplitude ratio and a bar graph representing the relative amplitude forall four evoked responses.